Making autologous cell therapies is a logistical challenge as much as a technical one. Material from the hospitalized patient must be transferred to a facility for processing before being returned for administration, all of which takes time and costs money.
In-hospital production is emerging as a viable alternative, which suggests a new generation of automated cell processing technologies could simplify and reduce the cost of making these innovative cures.
Stephan Kadauke, MD, PhD, assistant professor of clinical pathology and laboratory medicine at the University of Pennsylvania’s Perelman School of Medicine, calls these bedside, automated cell processing systems, “GMP-in-a-box.”
“Good manufacturing practice in a box essentially condenses the complex cell therapy manufacturing process into a more compact and automated system that can be housed within a hospital,” he says. “This not only automates an error-prone manual process but also eliminates the need to send cellular materials to centralized manufacturing facilities. We found that this can reduce the cost associated with delivery of novel cell therapies like CAR-T cells to patients. So the advantage is not just in cost, speed, and quality control, but also in patient access.”
Minimizing operator handling
In the study, Kadauke and co-authors looked at a range of in-hospital cell therapy production technologies and found that, although the platforms differ, all of them are designed to link multiple production steps while minimizing operator handling.
“The currently available systems involve a variety of technologies that handle cell selection, culturing, and quality control. Automation plays a significant role in these processes,” he points out. “The goal is to create a ‘one-stop-shop’ for producing cell therapies. The two most mature platforms are the Miltenyi CliniMACS Prodigy and the Lonza Cocoon. However, others are coming.”
Demand for these systems is likely to increase as healthcare professionals seek to improve access to cell therapies, according to Kadauke.
“In-hospital manufacturing is still relatively novel but is gaining traction. A few pioneering hospitals have already implemented such systems, and we expect to see more widespread adoption as the technology matures, especially in parts of the world that currently do not have access to these therapies.”
In addition, Kadauke predicts biopharmaceutical manufacturers will be interested in GMP-in-a-box systems.
“Biopharmaceutical companies also take advantage of GMP-in-a-Box systems to benefit from cost savings due to automation and standardized workflows, though our article focused on in-hospital applications,” he tells GEN. “A large wave of commercial cell therapy products is expected to hit the market in the next year or so, and products manufactured in-hospital with GMP-in-a-box systems will complement and coexist with current and novel commercial cell therapies.”
